The invention relates generally to nasal inhalers, and in particular, to a nasal inhaler suited for use with a nasal delivery device for the administration of a medication or other substance to the nasal cavity of a user.
The nose can be an important route for the delivery of various substances aimed at treating various ailments. For example, the nose, including its various nasal membranes, cavities and passageways, traditionally has been used as a route for the delivery of substances aimed at treating upper respiratory ailments, such as sinusitis, allergic conditions, reactive airway diseases, and rhinitis. Rhinitis is one of the more prevalent respiratory ailments and is characterized by the primary symptoms of sneezing, itching, and nasal obstruction. Substances commonly used to treat upper respiratory ailments such as rhinitis include anti-cholinergic agents, adrenegically acting decongestants, topical buffering compounds, and corticosteroid anti-inflammatory agents.
More recently, the nose also has served as a route for the delivery of various substances aimed at treating non-respiratory ailments, including, for example, migraines, diabetes, convulsions, anaphylaxis, anxiety, Parkinson""s disease, and erectile dysfunction. Substances used to treat these types of ailments can include, for example, pain medications and insulin.
Most of the substances delivered to a user through their nose, and in particular to the user""s nasal membranes, are delivered in aerosol or aqueous form through nasal delivery devices, including pressurized metered dose nasal inhalers, nasal spray containers, and dry powder inhalers. In order to ensure a positive therapeutic effect, substances delivered to the nose to treat the above noted ailments are preferably delivered to the area of the nose having a rich blood vessel plexus. This area of the nose typically is found on the lateral sidewall to the interior of the nose, and encompasses the squamous epithelisum prior to the transitional region to the nasal turbinates.
When delivering various substances to the nasal membranes, nasal delivery devices can cause irritation, infection, bleeding, and variable absorption. Most of these symptoms result from one or more disadvantages associated with such devices. For example, pressurized metered dose nasal inhalers often dispense aerosol particles at a high exit velocity, which can result in considerable pain to the user and may result in bleeding and infection. In addition, because of the pain associated with such velocities, users may have a tendency of aiming the outlet straight into the nasal cavity, instead of towards the interior lateral sidewall of the nose. In addition to pain, the high exit velocity of the particles may result in a narrow proximal deposition of the substance on the nasal membranes. Moreover, in many cases, the substance will be delivered on the nasal septum. Repeated delivery to the nasal septum can result in damage to the septum, including, for example, a perforation of the septum.
Alternatively, spray containers generally dispense the particles of substance at a lower exit velocity. However, the particle size is relatively large resulting in a large portion of the delivered substance coming back out of the nose and/or ending up at the back of throat, eventually making its way down to the stomach. This can result in a wastage of the substance, and can decrease the overall therapeutic effect on the user.
Briefly stated, one aspect of the invention is directed to a nasal inhaler for introducing a substance to the nasal cavity of a user. The nasal inhaler preferably comprises a chamber having an interior and an exterior. In a preferred embodiment, the chamber is flexible. An outlet comprises an exit passageway that is in flow communication with the interior of the chamber. The outlet is preferably shaped to be received in the nasal vestibule of the user. In a preferred embodiment, a single outlet is in communication with the interior. In an alternative embodiment, the nasal inhaler includes a pair of outlets spaced and configured to be received in both of the nasal vestibules of the user. A one-way air inlet valve is in one-way flow communication with the interior of the chamber at a location spaced from the exit passageway. The one-way valve is operative to permit one-way flow of air from the exterior to the interior of the chamber. A dosage inlet passageway is in flow communication with the interior of the chamber at a location spaced from the exit passageway and from the one-way valve. Preferably, the dosage inlet passageway and the exit passageway define axes that are not coaxial.
In a preferred embodiment of the invention, an adapter defines the dosage inlet passageway and is connected to the chamber. Preferably, the adapter comprises a handle having a grippable portion. In a preferred embodiment, the adapter is releasably connected to the chamber with a detent. Preferably, the detent comprises a combination of a rib and groove formed on one or the other of the chamber and the adapter. In an alternative embodiment, the adapter and the chamber are integrally formed.
In another aspect, the adapter is moveably connected with the chamber. The adapter is moveable between a retracted position, wherein at least a portion of the adapter is disposed in the interior of the chamber, and an extended position, wherein at least a portion of the adapter extends from the chamber. In one embodiment, an entirety of the adapter is disposed in the interior of the chamber when the adapter is in the retracted position. In other embodiments, at least a portion of the adapter extends from the chamber when the adapter is in the retracted position. Preferably, the adapter is releasably engaged with the chamber when in the retracted and extended positions so as to prevent axial movement therebetween.
In yet another aspect, a nose plug extends from the exterior of the chamber adjacent the outlet. The nose plug is shaped to be received in the nasal vestibule of the user. In one embodiment, the nasal inhaler includes a pair of nose plugs positioned on opposite sides of the outlet.
In a preferred embodiment, the one-way valve is formed by a valve opening formed in the chamber and a flexible valve member overlying said valve opening. In an exemplary embodiment, the flexible valve member is formed by a flexible portion of the adapter, which covers or overlies a valve opening formed in the chamber. In another exemplary embodiment, the valve member is separate from the adapter and overlies a valve opening formed in the chamber.
In another aspect of the invention, a method for dispensing a substance into the nasal cavity of a user is provided. The method includes providing a container that holds a substance and which comprises a dispensing portion. The dispensing portion is disposed in the dosage inlet passageway. The outlet is inserted into a nasal cavity, and the substance is dispensed into the chamber. In a preferred embodiment, the user inhales through the outlet so as to draw the substance through the outlet and into the nasal cavity. At the same time, air is drawn into the chamber through the one-way valve. In a preferred embodiment, the user can further compress the chamber to force the substance through the outlet. Preferably, the substance is dispensed into the chamber at a first velocity and is drawn into the nasal cavity through the outlet at a second velocity, wherein the second velocity is less than the first velocity. In alternative embodiments, the substance is forced out of the chamber through the exit passageway and into the nasal cavities without inhalation by the user. For example, the substance can be dispensed solely by compression of the chamber or as a result of the substance being forced into the chamber, for example, by way of a pressurized metered dose nasal inhaler.
In yet another aspect, a method of assembling a nasal inhaler assembly is provided. Preferably, the method comprises connecting an insert portion of an adapter with an intake portion of the chamber, such that the dosage inlet passageway is in flow communication with the interior of the chamber. The dispensing portion of the container is then disposed in the dosage inlet passageway. In one embodiment, a first adapter can be disconnected from the chamber, and a second adapter can thereafter be connected to the chamber.
In yet another aspect, a mask is connected to the outlet extending from the chamber. The mask can be disposed over the nose of the user so as to allow the substance to be dispensed to the user via the mask.
The present invention provides significant advantages over other nasal inhalers, nasal delivery devices, and combinations thereof. In particular, the chamber, and the configuration of the outlet and the dosage inlet passageway, allows for the substance to be introduced into the chamber at one velocity, and thereafter dispensed to the user at a second, lesser velocity. In this way, any discomfort to the user caused by the impaction of the substance on the user""s nasal membranes can be reduced. At the same time, due to the associated decrease in pain experienced by the user, the user may be less likely to direct the outlet straight into the nasal vestibule, rather than towards the preferred lateral side wall of the nose. In addition, the substance is more evenly distributed in the nasal cavity, and the likelihood of a perforation of the septum can be reduced. At the same time, the substance is entrained in an aerosol form in the chamber, whereinafter it can be dispensed to the user in a more controlled and evenly distributed manner. For example, the velocity of the substance can be reduced to approximate the rate of inhalation, which allows the substance to be more evenly distributed over the target area.
In addition, a chamber made of a flexible material can be compressed or squeezed to facilitate the dispensing of the substance from the chamber through the outlet. This can be particularly helpful when the user has decreased lung capacity, or is experiencing nasal blockage, both of which can prevent inhalation through the nasal passageways. At the same time, the one-way valve prevents air from being pushed out of the chamber through the valve, thereby forcing the air through the air exit passageway.
A separate adapter also provides various advantages. For example, a single chamber can be used with different types of adapters that are configured to mate with various types of containers, including, for example, various spray containers, pressurized metered dose inhalers, and dry powder nasal inhalers. Conversely, a single container can be used with different types of adapters that are configured to mate with various chamber configurations. In either case, the detent or snap-fit coupling between the adapter and chamber allows for quick and easy assembly and disassembly of the nasal inhaler. Likewise, the releasable connection between the container and the adapter allows for easy assembly and disassembly.
Moreover, in certain embodiments, the adapter can be moveably retracted into the chamber for ease of storage and enhanced transportability. The adapter, when configured with a handle, also can facilitate the dispensing of the substance from the container, as the user can grip the handle and container and effect an actuation by moving at least one of the container or adapter toward the other.
The present invention, together with further objects and advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.